NCT05443724

A Study to Evaluate Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia

A 52-week, Phase 2, Open-label Trial to Evaluate the Long-term Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the long-term safety and tolerability of oral emraclidine in adult participants with schizophrenia.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	CVL-231 30 mg	Oral tablets

Timeline

• Start date: 2022-09-02
• Primary completion: 2025-06-25
• Completion: 2025-06-25
• First posted: 2022-07-05
• Last updated: 2025-07-28

Locations

85 sites across 5 countries: United States, Bulgaria, Hungary, Puerto Rico, Ukraine

Regulatory

• FDA-regulated drug study